Why Return of Results Matters
In October, Color and Verily announced a partnership to return actionable genetic information to the participants of the Project Baseline Health Study. The partnership was not only a commitment to research, but also a recognition of an ethical responsibility for the return of actionable results.
Individual participants in genetic research studies often don’t receive their genetic results, even if their results indicate a high level of risk for certain health issues. In early genetic studies, returning results to all participants was not feasible due to high costs and logistical constraints. Now, however, participant results can be returned efficiently and cost-effectively — and Color believes returning genetic results to research participants is not only an ethical choice, but one that will lead to more successful research programs that have increased levels of trust between researchers and participants.
When a participant decides to contribute to a research program that includes genetic testing, it is a fundamental expression of generosity — they are providing a piece of themselves for a course of research that may not affect their lives. For a research program to be successful, researchers must constantly earn the trust and goodwill of participants. This is where return of results comes in. When research sponsors like Verily support the responsible return of actionable results , they acknowledge the participant as an individual, as someone who should have the right to know what was found in their genetic test. In sequencing participants, researchers may discover something of clinical significance in a participant’s sample — important information that the participant should know.
Some will make a distinction between medical research and clinical practice — and we agree that a boundary exists. Research endeavors to broaden knowledge and clinical practice seeks to improve an individual’s health, which is why Color has collaborated with partners in both spaces to augment their goals with the responsible return of results, whether the individual is a patient or participant. With Color’s clinical grade genomic services, including physician-ordered genetic tests, board-certified genetic counselors, and clinical pharmacists, research participants can better understand their risk for certain hereditary cancers, heart disease, and genes that may impact medication response.
Historically, it has been accepted in the research community that participating in a study simply meant contributing to a common good, even though participants would not get anything in return for their contributions. At the time, delivery models didn’t exist that could return results to participants in a cost-effective, responsible and accessible way, but times have changed. Returning this information is no longer cost-prohibitive and Color provides a model of delivery that makes it simple to responsibly return results — so the original understanding no longer makes sense.
We’re proud of our partnership with Verily. By providing actionable information to Project Baseline participants, we believe we are a model for future research programs to responsibly return clinical results to generous participants.
Color is the leader in delivering precision healthcare through cutting-edge technology. Color makes data-driven health programs such as clinical genetics accessible, convenient, and cost-effective for everyone. Color partners with leading health systems, premier employers, and national health initiatives around the world including the million-person All of Us program by the National Institutes of Health. For more information about Color, visit www.color.com